Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010829427

FEI Number

3010829427

Entity Name

SWANTIA MEDICAL PRIVATE LIMITED

City/State/Country

Sialkot Punjab, PK

Establishment Address

P.O.S.I. Estate, Defence Road, Sialkot Punjab 51310, PK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SWANTIA MEDICAL PRIVATE LIMITED (Owner Number: 10080452)

Owner / Operator Contact Address

P.O.S.I. Estate, Defence Road, Sialkot, PK-PB 51310, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CURETTE, EAR RETRACTOR, SELF-RETAINING HOOK, SURGICAL, GENERAL & PLASTIC SURGERY SPECULUM, VAGINAL, METAL RETRACTOR, ENT HANDLE, SCALPEL SOUND, UTERINE MARKER, SKIN CURETTE TUBE, TONSIL SUCTION FORCEPS HEMOSTAT RETRACTOR, VAGINAL TAPE, MEASURING, RULERS AND CALIPERS SOURCE, CARRIER, FIBEROPTIC LIGHT CURETTE, NASAL TRAY, SURGICAL Nasal trocar DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY PUNCH, SURGICAL MALLET PLIERS, SURGICAL GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY INSTRUMENT, MANUAL, SURGICAL, GENERAL USE RASP FORCEPS, GENERAL & PLASTIC SURGERY CURETTE, ADENOID Wire baskets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2021-02-02
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2021-02-03
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-04-01
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2024-01-04
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2021-02-03
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2021-02-03
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2021-02-03
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2021-02-03
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2021-02-03
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2021-03-24
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2021-02-03
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2021-02-03
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2021-02-03
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2021-02-03
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2021-04-01
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2021-02-03
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-02-03
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-05-30
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-02-03
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-04-01
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2021-02-03
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-02-03
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-04-01
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-04-01
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-02-03
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2021-02-03
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-02-03
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2021-02-03
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-11-29

Official Correspondent

No official correspondent registered.

US Agent Details

Jay Mansour Business: Mansour Consulting LLC Email: jay@mansourconsulting.com Phone: (678) 9088180

Related Public Records

Same Entity

SWANTIA MEDICAL PRIVATE LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
9680518	CM INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3010155661	Synergy Health Sterilisation UK Ltd	Thorne Doncaster, GB
3010455030	ENDO TECH INSTRUMENTS	Sialkot Punjab, PK
9680837	INTEGRA MICROFRANCE SAS	SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR
2916714	AESCULAP, INC.	CENTER VALLEY, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010829427. Last updated year: 2026. Please use registration number 3010829427 when referencing this establishment in official correspondence.